Tissue heating and monitoring system with seat

ABSTRACT

A system is described having a heating device with a focused antenna array, a chair, a cabinet, at least one temperature monitoring device, a cooling system, and a controller. The system may be used to heat and monitor internal tissue and/or fluid in an individual in a non-invasive way.

RELATED APPLICATIONS

This application claims benefit and priority from U.S. ProvisionalPatent Application Nos. 61/156,444, 61/156,441, 61/156,438, 61/156,433,61/156,427, 61/156,407, 61/156,401, 61/156,393, 61/156,382, each filedon Feb. 27, 2009, and each of which is incorporated herein by referencein its entirety.

This application is part of a group of similar applications which alsoincludes U.S. patent application Ser. No. ______ filed Feb. ______,2010, Attorney Docket Number 4311.THER.NP; U.S. patent application Ser.No. ______ filed Feb. ______, 2010, Attorney Docket Number 4313.THER.NP;and U.S. patent application Ser. No. ______ filed Feb. ______, 2010,Attorney Docket Number 4314.THER.NP.

FIELD

This application relates generally to noninvasive thermal therapy anddiagnostic devices and methods. More specifically, the present inventionrelates to devices and methods to non-invasively heat bodily tissues andfluid using emitted energy and non-invasively measure the resultingtemperature changes in the target and surrounding fluid and tissue todetect and/or treat for various physical conditions, such as, forexample, vesicoureteral reflux.

BACKGROUND

There are numerous diseases which can be treated successfully ifdetected early, but which can cause long term damage if not timelydiagnosed and treated. Diseases such as vesicoureteral reflux can causesignificant harm to an individual, but are not easily diagnosed withoutinvasive procedures.

In vesicoureteral reflux bladder urine flows back up into the uretersand into the kidneys. The urine can cause kidney infections which can bepainful. Moreover, repeated infections can cause long term kidneydamage. While vesicoureteral reflux can be treated with medication or bysurgical techniques, vesicoureteral reflux is difficult to properlydiagnose.

Approximately 2% of all children at any one time have a urinary tractinfection. When a child has had more than one kidney infection, it isdesirable to determine if the child has vesicoureteral reflux. Tworadiologic imaging studies are commonly utilized: voidingcystourethogram (VCUG) and a nuclear cystogram. A VCUG is performed inhumans of all ages by first placing a sterile catheter in the patient'surethra and through the catheter instilling radiopaque contrast, such asCystografin. The kidneys and bladder are observed during a bladderfilling and emptying cycle using x-rays. The patient has an initialx-ray film taken, then an anterior-posterior film and then films in eachlateral oblique. When voiding is initiated, fluoroscopy is utilized, andspot films are taken to document changes during voiding. This processhas been necessary to evaluate bladder anatomy, function, eliminationand confirm the existence of vesicoureteral reflux. After the firstinfection it is currently recommended that patients undergo a VCUG and arenal imaging study. However, doctors are sometimes reluctant to orderthe invasive VCUG until other infections occur. Of the VCUGs performed,approximately one of three patients will have vesicoureteral reflux. Thereflux is graded and treatment is assigned on the basis of severity.About three-quarters of the patients are assigned to medical managementand are screened with a VCUG each year until their reflux resolves. Thisaverages about three years of waiting before resolution occurs. Patientswho undergo surgical correction of their reflux also require a follow-upVCUG to evaluate the success of the procedure. Patients with enuresiseither at night or during the day are evaluated with VCUGs on occasion.Since the test is currently invasive it is withheld until the patientsare older or unusual symptoms indicate its necessity. It will beappreciated that the VCUG procedure is uncomfortable and can betraumatic, particularly for children.

Likewise, various other conditions exist in which body fluids, such asurine or blood, improperly flow as a result of disease or dysfunction.For example, gastroesophageal reflux is common in young children. Otherconditions involve disruptions in blood flow or myocardial functionresulting from narrowing of the aorta, blood clots, or malfunction ofthe enterohepatic circulation or a portion of this system, e.g. theintestine, liver or gall bladder, or disruptions in flow ofcerebrospinal fluid. Diagnosis of such conditions has often requiredinvasive procedures such as use of catheters or tubes.

Besides the diseases above, body tissues are subject to otherabnormalities including cancer, scarring, inflammation and reducedfunction. One potential effect of the abnormalities includes abnormaltissue abnormally encouraging or restricting thermal spread. Thus, theimproper flow of bodily fluids may be a condition that should betreated, or may be a symptom of a disease in need of treatment. Eitherway, prompt detection of such conditions would be beneficial.

There has been some discussion regarding administering microwave orultrasound energy through an external energy source to warm a fluid in atarget organ or tissue and detecting a warmed fluid distant from thetarget. (See e.g. U.S. Pat. No. 7,271,245). However, blind applicationof the thermal energy for a predetermined time may cause many problems,such as mis-targeting of the device, over or under heating of the targetarea, skin burns by mis-placement of the device and/or uncomfortable ordamaging heating of the antenna itself against the patient.

There has also been discussion about a flexible microwave antenna arrayon a flexible circuit board. (See e.g. U.S. Pat. No. 6,330,479).However, sensing deep tissue temperature in a non-invasive manner can bedifficult, as the emitted energy is small.

As diseases such as vesicoureteral reflux have relied on invasive andtraumatic diagnosis procedures, a non-invasive and less traumaticdiagnosis method and equipment would be desired. Moreover, a method fordiagnosing or treating diseases with thermal energy which does not burnor otherwise discomfort patients would also be desirable.

SUMMARY

Embodiments of improved noninvasive heating and monitoring devices andmethods of use are disclosed below. According to some embodiments, oneor more microwave antennas are directed at a target organ or tissue,such as the bladder. Signals broadcast by the antenna(s) are used toheat liquid within the targeted tissue or organ (e.g. the bladder, gallbladder, etc.). A temperature sensing device, such as a radiometer, maybe directed at the target organ or tissue and its temperature monitoredto determine the extent to which heating has occurred at the desiredlocation. The temperature sensing device or a second temperature sensingdevice may then be directed at a secondary location to detect anabnormal rise (or abnormal lack of rise) in temperature. If thetemperature sensed at the secondary location is other than what would beexpected in a healthy individual, a reading can be taken which isindicative of a disease or dysfunction. While discussed principally inthe context of urine, other body fluids such as blood, bile,cerebrospinal fluid, lymp or other gastric fluids could also be used todiagnose abnormal physical conditions. Similarly, the target organ ortissue may be monitored for an abnormal dissipation of heat as evidenceof disease/dysfunction.

In some embodiments, a heating and monitoring device includes an arrayof microwave elements that direct energy to a focal point or area. Theseelements may be controlled separately or as a single entity Likewise,the microwave elements can be used simultaneously or alternatingly toobtain desired heating characteristics.

The elements may be alternately activated such that the focal point issubject to a more consistent thermal energy from alternating microwaveelements. However, by alternating the elements, the tissue between theelements and the focal point is subject to only the energy of a singleelement and at less frequently than the focal point. Thus theintervening tissue may maintain a lower temperature, while the focalpoint may be heated to a desired temperature. This may reduce andhopefully eliminate discomfort or burns to the surface tissue orintervening tissues, while providing enough energy to heat the focalpoint to obtain the desired temperature.

Some embodiments of the present invention provide for a noninvasivemethod for determining the condition of tissues by administeringexternal energy with an array device to heat a tissue while measuringthe temperature changes and heat dissipation of the tissue and comparingto measurements of temperature changes in normal tissues when heated.For example, in some embodiments, an array of microwave elements mayinclude one or more passive elements or sensors that may be used tomonitor the temperature of the surface area of the tissue. If thetissues at the surface approach a threshold, the sensors can signal analarm or may alter the application of energy from the elements. Thisensures that the surface temperature does not exceed desired limits andprevents burning or causing discomfort in the individual.

In some embodiments, temperature monitors, may be further enabled orenhanced to enable more accurate deep tissue readings. The device may beconfigured, for example, to disable the active elements (i.e. energyapplying elements such as microwave antennas) to reduce any noiseproduced by the active elements. A passive element or sensor may thentake may take readings between application of energy from the elementsto obtain a more accurate temperature measurement due to a decrease inbackground noise or signals.

The monitors may also be directionally shielded such that the sensor mayhave increased sensitivity at the desired anatomy, and minimizedsensitivity to radiated heat from other tissues. The increasedsensitivity and decreased noise may be especially important fordeep-tissue or organ observation as the received signal may be as smallas −160 dBm.

In some embodiments, the surface area around the microwave elements maybe cooled. In some embodiments, the microwave elements may be coveredwith passive cooling mechanisms such as water or gel (i.e. a heat sink),to reduce the risk of burns caused by the microwaves. Alternatively,active cooling mechanisms, such as a heat pump, a heat pipe,recirculator, a refrigerated coil, etc., or any other cooling mechanismcan be used to keep tissues near the surface cool while deeper tissuesare heated.

In other embodiments, monitoring the surface temperature may be used tocontrol how the microwave elements are powered or which of the arrayelements are active at any particular time. By modulating the power orby selectively activating different elements in the array, the surfacetemperature and the internal energy deposition at any point may be keptlow while still heating the internal target area.

The focal area or another area may be monitored for temperaturedifference after heating by a detecting mechanism such as an antennadisposed in communication with a radiometer. Heat dissipation from thefocal area different from normal or control tissue may indicate diseaseor dysfunction. Similarly, tissue or liquid distant from the focal areamay be monitored for unexpected rise, lack of rise or decrease oftemperature which may indicate dysfunction or disease, such asvesicoureteral reflux, gastroesophageal reflux, or a number of otherdiseases.

For example, one or more focused antennas disposed in communication withone or more antennas in communication with radiometers may be positionedon the body of an individual to monitor the temperature change of tissueand/or fluid at a desired depth within the body, such as for detectingfluid temperature in the bladder or some other organ. In someembodiments, focused antennas be placed such that a change intemperature in the kidneys due to reflux of heated urine from thebladder may also be monitored and thus determined non-invasively. Thisenables a physician to determine that there is vesicoureteral reflux,gastroesophageal reflux, etc., without having to use a catheter or otherinvasive procedure and potentially traumatize the individual.

Some embodiments of the present invention may include a chair or seatconfigured to be used with heating and monitoring systems that provide asecure and comfortable resting position for an individual beingdiagnosed or treated. In some embodiments, the seat may include portionsof the array or monitoring devices, and may further be shielded toprevent or reduce microwave energy from reaching undesired areas. Insome embodiments, the seat may be in the general form of a child carseat, with restraints and other features generally known to children.The seat may be positioned on or next to a cabinet containing equipmentfor use with the system, such as a computer and focused microwaveantennas Likewise, the seat or seat can be configured for an adult withthe heating and monitoring systems being removably attached or built in.

In some embodiments of the invention, garments for wearing by theindividual being tested may be formed similar to a diaper or othergarment and configured to hold a heating array against the individualand in proper position. Similarly, the garment may be configured to workintegrally with the system to provide for comfort and safety during anyprocedure. For procedures involving the bladder, the garment may beconfigured as a diaper (or adult undergarment) with an absorbent layer,since testing urinary reflux requires the individual being tested toattempt to evacuate the bladder and urinate. In some embodiments, thegarment may include positioning aids to assist in properly positioningthe garment on the individual. The garment may also include shieldingmaterial to reduce unwanted escape or transmission of microwave energyto unwanted locations.

These and other aspects of the embodiments of a heating and monitoringdevice are shown and described in the following figures and relateddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments and features of heating and monitoring devices areshown and described in reference to the following numbered drawings:

FIG. 1 is a schematic view of an emitted energy heating and monitoringsystem;

FIG. 2 is a schematic view of an emitted energy heating and monitoringdevice;

FIG. 3 is a cross sectional view of an emitted energy heating andmonitoring device in use on a individual;

FIG. 4 is a functional representation of an emitted energy heating andmonitoring system;

FIG. 5A is a functional representation of an exemplary heating andmonitoring device holder in the form of an undergarment;

FIG. 5B is a cross sectional view of the device holder in FIG. 5A; and

FIG. 6 is a cross-sectional view of an alternate garment having aheating system and monitoring system formed therein

It will be appreciated that the drawings are illustrative and notlimiting of the scope of the invention which is defined by the appendedclaims. The embodiments shown accomplish various aspects of theinvention. It is appreciated that it is not possible to clearly showeach element and aspect of an invention in a single figure, and as such,multiple figures are presented to separately illustrate the variousdetails of embodiments of heating and monitoring devices in greaterclarity. Several aspects from different figures may be used inaccordance with the heating and monitoring devices in a singlestructure. Similarly, not every embodiment need accomplish alladvantages of various embodiments of heating and monitoring systems.

DETAILED DESCRIPTION

Embodiments of heating and monitoring devices and associated methods asshown in the accompanying drawings, which include reference numeralsreferred to below, provide details for understanding and practice by oneskilled in the art. The drawings and descriptions are exemplary ofvarious aspects of heating and monitoring systems and associated methodsand are not intended to narrow the scope of the appended claims.

Turning now specifically to FIG. 1, a schematic representation ofnon-invasive energy emitting heating and monitoring system 10 is shown.System 10 is shown being used to diagnose a potential abnormal conditionon a body 70 by applying heat to a bladder 20 filled with urine 30 tosee if the urine flows back to the body's kidneys 60. The system 10typically includes a heating assembly 100, a control assembly 150, and amonitoring assembly 160.

The heating assembly 100 typically includes microwave elements 110, 112.As will be explained in additional detail below, the microwave elements110 and/or 112 can be used to heat tissue or fluid and can be used todetermine the temperature of those tissues. The microwave elements 110and 112 may be attached to a substrate 120, and may also include acooling element or system 140 which is designed to cool tissue at ornear the surface while deeper tissue is being heated by the heatingassembly 100.

Microwave elements 110 may be directional microwave emitters, commonlyknown as antennas, and may be configured to supply energy to a specificarea in a body 70. For example, microwave elements 110 may be configuredto provide microwave energy directionally into a bladder 20 filled withurine 30 so as to heat the urine. Likewise, the elements 110 can be usedto heat fluid in other body tissues.

It should be recognized that while much of the discussion about anindividual may be related to an adult human, the term individual shouldbe read broadly to include children and animals.

To protect against burning or discomfort, temperature sensors 113 may beprovided in the heating assembly 100 for detecting temperature at ornear the surface of the individual's body 70. If the sensors 113 detectexcess heat, an alarm may be provided, or the heating protocol adjustedto address the situation. Different adjustments are discussed below inadditional detail. (It will be appreciated that the heating assembly 100and the monitoring assembly 160 may be a single unit in certainapplications.

As the elements 110 are used to heat the target area, it is important tomonitor temperature in the target area to prevent overheating. This canbe accomplished by the heating assembly using one or more of theelements 110, 112 to detect signals from the target area which are thenpassed to a radiometer 180 a which indicates the temperature in thetarget area. While it is possible to use active elements 110 after theyhave been turned off, it is presently preferred to use passive element112 to detect the temperature in conjunction with the radiometer 180 a.

Likewise, in certain applications, temperature sensors (e.g. focusedantennas) in the monitoring assembly 160 can be use to detecttemperature of the target location being heated and/or to detect thetemperature in a remote locations, such as the kidneys 60, to ensurethat excess heat is not provided, and to gather data used to diagnose anabnormal condition. Thus, for example, focused antenna(s) 162 in themonitoring assembly 160 may collect signals and communicate with one ormore radiometers 180 b to indicate the temperature at or adjacentkidneys 60.

A control assembly 150 may monitor the system 10 for safety, record theobserved results and display the results to the system 10 operator.Thus, the operator may simultaneously monitor the application of heat to(or creation of heat within) one part of the body 70 and detect changesin heat at a second location.

In the heating assembly 100, microwave elements 110 may be placed in anarray, and may be arranged and/or spaced apart from each other in thearray such that microwave elements 110 provide for a convergence pointor area, such that focal area 116 may be affected by the aggregateenergy of each of microwave elements 110. Since each of microwaveelements 110 may be directional, the energy emitted by microwaveelements 110 may travel through body 70 in a generally columnarapplication. Microwave elements 110 may be arranged in an array in sucha way that the convergence of each of microwave elements 110 occursprincipally or entirely in the interior space of bladder 20, heatingurine 30. This may be accomplished by placing the elements 110 on aflexible substrate 120 or by use of a rigid substrate which can haveconnections (i.e. pivot attachments) which allow the elements 110 to beangled to adjust for the depth of the target. (For example, a bladder onan overweight adult will be much deeper than a bladder on a thin child).Alternatively, the heating assembly 100 could be preconfigured forvarious depths of target tissue, with the physician selecting theassembly which is most appropriate for a particular individual.

In some embodiments, anatomy may be consistent enough to allow a holderto naturally direct microwave elements to the target tissue based onplacement on the skin. In one embodiment, the physician selects aheating assembly that conforms to the surface of the individual. Whenplaced on the skin using the individual's anatomy as a guide, theelements naturally focus to a target tissue. The holder may includepivot attachments that may have markings that allow the elements to beadjusted based on specific characteristics of the individual such asheight, weight, and/or girth.

Generally, each of the columnar energy emissions heats all tissue orfluids within the columnar area. Thus, focal area 116 will receive anaggregate of the combined energies of the overlapping columnar energyemission areas for that area, increasing the energy absorption andsubsequent heating of urine 30 within bladder 20. With four microwaveelements 110 as shown in the embodiment illustrated in FIG. 2, theamount of energy applied to the surface of body 70 and other tissues andfluids outside of the targeted focal area 116 may be reduced from thatof a single microwave element 110, spreading out the energy over alarger surface area and volume of tissue while not diminishing theenergy absorbed in focal area 116. For example, in an array with fourmicrowave elements 110, the skin of body 70 located directly undermicrowave element 110 will typically receive less energy than would havebeen required to heat urine 30 with only a single microwave element 110.

In some embodiments, microwave elements 110 may be designed such thateach microwave element 110 emits a generally columnar energy emission.In some embodiments, the dimensions of the columnar energy emission maybe selected to maximize the profile of focal area 116 while minimizingexcess heating of surrounding tissues. The columnar shape or lobes ofthe radiated energy may be of any configuration desired by apractitioner to provide energy to a focal area 116.

The energy from microwave elements 110 may be additive when supplied toand absorbed by focal area 116. For example, the energy from each of theoverlapping focal planes contributes to the energy received by the focalarea 116. Adjusting the overlapping focal planes may maximize the energyapplied to focal area 116, while minimizing the energy applied totissues outside of focal area 116. Based on the geometry of the array ofmicrowave elements 110 on heating assembly 100, the energy emitted fromthe array may be further maximized by adjusting transmission times,direction, frequency, and amplitude of the energy emitted.

For example, in some applications a first element 110 could emit a highenergy emission for a few seconds and then cease. The element 112 couldquickly monitor the temperature of the bladder 20 and then a secondelement could emit a high energy emission for a few seconds, followed byadditional monitoring of the temperature of the bladder 20. The processis repeated until the bladder has reached a desired temperature.However, the tissue between the bladder and any given element 110 wouldheat much less than if a single heating element were used. Moreover,blood passing through non-target tissues would tend to conduct heat awayfrom said tissues, while the liquid in the bladder would tend to retainthe heat. Between alternating application of energy and the conductivecooling, the heating in the bladder will be significantly greater thanthe other tissues.

In other applications, each of the elements 100 (whether it be four or adifferent number) could be activated in sequence and then the element112 and radiometer 180 a used to check the temperature of the target. Byapplying energy from multiple locations, the heating of tissue otherthan the target tissue is reduced, lessening the likelihood of burns ordiscomfort.

Providing a plurality of different application protocols is desirablebecause different tissues or other intervening structures have differentreactions to microwave energy. According to our experience, tissues withhigher salt content will absorb more microwave energy than lower saltcontent tissues. The bladder and muscle tissue have been observed toabsorb more energy than fat tissue. Vascular tissues, such as muscletissue, appear to cool faster than non-vascular tissue or staticliquids, such as the bladder.

Taking advantage of this experience, the microwave elements 110 may beactivated in different ways depending on factors such as interveningtissue and focal area. For example, when the intervening tissue andstructures may be vascular and/or less responsive to microwave energy, ahigher power, multiple element simultaneous activation and/or longerduration may be used because of the ability of the tissue to cool and/orabsorb less energy. Similarly, if the focal area 116 is within a staticliquid with a higher salt content, a higher power, multiple elementsimultaneous activation and/or longer duration may be used due to thelikely better heating of the tissue and/or structure.

In other situations it may be advantageous to use lower power,alternating microwave element activation and/or shorter duration. Insome cases, it may be advantageous to mix the activation, duration andpower settings. For example, in one embodiment, when heating urine,multiple microwave elements may be activated for a short duration withlonger periods for conductive cooling.

For example, in one embodiment with four antennas numbered A, B, C andD, the process of heating urine may be the following. Antennas A and Care activated for a short time at high power. The antennas arede-activated and the radiometer readings are examined. If a highertemperature is desired, antennas B and D are activated for a short timeat moderate power or high power depending on the sensed temperature. Theradiometer readings are then consulted again. If more power is desired,then the process repeats with A and C again.

The process allows the intervening tissue of A and C to cool during theradiometer readings and B and D's activation. Furthermore, it aids inpreventing noise during the temperature reading from the passive element112 and radiometer 180 a, as the radiometer may be detecting a smallsignal that may be on the order of −160 dBm.

In some embodiments, the attitude of each microwave elements 110relative to each other may be fixed such that the location of the focalarea is known based on the physical configuration of heating assembly100. Similarly, in some embodiments, substrate 120 may be rigid toprovide structure to allow fixed relative positioning of microwaveelements 110. In other embodiments, rigid microwave elements may beplaced on a flexible structure that is carefully placed and may beadhered to the individual. The placement on the body acts as the fixedrelative positioning of the microwave elements.

Microwave element 112 may be a passive antenna for monitoringtemperatures of portions of body 70. For example, microwave element 112may be a passive element for measuring the condition, includingtemperature, specific heat, rate of heat dissipation, etc., of the focuspoint or focal area. In some embodiments, Microwave elements 110 may beused to both emit microwave energy when active, and passively to monitorconditions of tissue, such as temperature, when not emitting energy(although such would be more difficult than using a passive element forsuch monitoring). In such embodiments, microwave element 112 may not benecessary. Similarly, in some embodiments, microwave element 112 may bereplaced with a focused antenna similar to those in the monitoringsystem 160 which are in communication radiometer 180.

However, in deeper tissue sensing, it may be more advantageous to have adedicated sensing antenna as the passive antenna. For example, thetemperature signal strength from heated urine may be as small as −160dBm. Thus, increasing the signal to noise ratio may be advantageous.

Noise may be reduced by methods including shielding and reducing activeinterference. The passive antenna/element 112 may be provided with ashield 115 so that detection only occurs in the direction of a targetarea of the body. Any cable connections between the antenna/element 112and the receiver, such as radiometer 180 a, may be shielded to reducenoise. Active microwave elements 110 may be shielded (i.e. shield 117,FIG. 3) to provide directionality to the focal area while reducing oreliminating other directionality. Active interference may be reduced bycausing the active microwave elements 110 to cease transmitting during awindow of time that sensing may occur (a.k.a. a sensing window). Furtheractive interference may be reduced by causing portions of the controlequipment to shut down during a sensing window. In some cases, it may beadvantageous to combine the radiometer 180 a and passive antenna/element112 into a single unit that may be placed on the individual. Such a unitmay contain one or more of the following a focused antenna, radiometer,output to a computer, a shielding enclosure and an analog to digitalconverter.

Impedance matching of the radiometer 180 a to the body may also beimportant in signal quality. The impedance may be matched through thefixture 121 (FIG. 3) (i.e. strap or other retention mechanism) to whichthe antenna is attached. For example, the fixture 121 may use a foam padto not only conform to the skin's shape, but also impedance match theradiometer to the body. One or more of the passive antenna fixtures maybe different than the microwave antenna array fixture, as they may bedirected at different anatomy.

In some embodiments, temperature sensors 132 may be used to monitor thesurface temperature of body 70 in specific locations, or may be used tomonitor the temperature of a cooling system 140. For example, in someembodiments temperature sensors 132 may be placed adjacent to eachmicrowave element 110, as well as in other areas, to monitor surfacetemperatures of body 70, and in cooperation with control assembly 150,to reduce the possibility of tissue damage or surface burns. Temperaturesensors 132 may be any type of temperature sensor configurable to sendelectronic signals, such as thermistors, thermocouples, or any othersuitable devices.

Control assembly 150 may include PC 152 (or other microcontroller,control system, etc.), heating control 156, amplifier 158 andmultiplexer 114 (for controlling heating assembly 100), cooling systemcontroller 142, and radiometers 180 a and 180 b. I/O devices 154 may beprovided for user interaction and input with system 10. Heating control156, amplifier 158, and multiplexer 114 may be used, along with PC 152,to control the output of microwave elements 110.

In some embodiments, microwave elements 110 may be activated andde-activated in a pattern or sequence to limit potential damage to body70, while obtaining the desired heating of an internal organ or tissue.Microwave elements 110 may be activated and de-activated simultaneously,or may be selectively activated and de-activated individually and/orconcurrently with one or more other microwave elements 110 in a pattern.The power, duration, and sequence of activation of microwave elementsmay be controlled by heating control 156. The control may further berefined based on measured surface temperatures of body 70, temperaturesof cooling device 140, or based on any other desired input or parametersuch as a pre-determined energy output profiles or individual physiologyand anatomy. Thus, heating control may depend on such factors as bodyfat content, bladder size/fullness and the size of the individual.

For example, when heating urine, multiple elements may be activatedsimultaneously for a short duration at a desired energy level (low,medium or high) followed by an inactive refractory period. Blood flowfrom vascular tissues, such as muscle, rid the intervening tissue ofexcess heat. Since the bladder does not have a similar blood flow, theurine will stay heated.

In some embodiments, amplifier 158 may provide microwave energy tomicrowave elements 110 through multiplexor 114 or from individualamplifiers. Preferably, the energy is in the microwave ISM bands, with apreferred frequency range of 902 MHz to 928 MHz with a preferredfrequency of 915 MHz. However, other models outside the U.S. may need touse alternate ISM bands. Therefore a frequency range of 863 MHz to 870MHz may also be desirable in other countries, such as those in Europe.The microwave energy supplied by amplifier 158 may be about 100 W atabout 915 MHz. Each of microwave emitters 110 may be capable of emittingthe entire output of amplifier 158, or some portion thereof.

In contrast, the energy received by a sensor such as the radiometer 180a or 180 b may be between about 1-4 GHz. In fact, the energy emitted bythe body 70 is believed to correspond to an integral of the heat of allthe tissue to the detected depth. The detected depth is believed todepend on the frequency selected. Thus a measurement at two differentfrequencies may correspond to a heated volume. The heated volume maythen correspond to a temperature at the heated volume. Thus, amulti-frequency radiometer or two or more radiometers may be used todetect and/or quantify temperature at a depth in a non-invasive way bycomparing first and second energy levels. Another benefit ofmulti-frequency radiometers is that depth may be adjusted on a perindividual basis. In some embodiments, the frequency emitted may moreparticularly be between about 1.2-1.4 GHz.

These results may then be compared to an actual, normalized or expectedenergy level. The normalization may be based on anatomical data. In oneembodiment, the examined depth may be between 2 cm and 7 cm. In oneembodiment, the measured levels are presented by an image. The image maybe based on actual values or calculated values, such as a delta betweenactual and expected values. In some cases, quantifying the data mayrequire integration to determine an aggregate of energy change.

In some embodiments a target of total energy supplied by system 10 tobody 70 may be about 5 W to 60 W over about 5-20 min. The amount ofenergy emitted should be sufficient to heat the targeted body portion toa desired temperature, such as raising the temperature of urine 30 ameasurable amount over body temperature. The target temperature may besufficient such that the heated urine may be detected in the kidneysduring a reflux event, but not so hot as to damage tissues or causesignificant discomfort. Heating assembly 110 may be connected to controlassembly through connector 114.

In some embodiments, cooling system 142, along with cooling element 140,may be used to cool the surface of body 70 at or near where heatingassembly 100 supplies energy to body 70. In one embodiment, coolingsystem 142 may circulate and monitor cooling fluid through coolingelement 140. The cooling system 142 may also alternatively activelyremove heat from the area using a heat sink, heat pump, heat pipe, orother similar devices alone or in combination, as represented bystructure 143. Cooling system 142 may provide signals to heatingcontroller 156 indicating the temperature and status of the coolingsystem and/or surface of body 70, such that the system may maintain asafe operation. In one embodiment, the cooling system is controlledbased on signals from the controller.

In some embodiments, system 10 may not have cooling system 142, but onlycooling element 140. Cooling element 140 may be a cooling gel, water, orother cooling medium or device. In some embodiments, cooling element 140may be configured to be replaced intermittently as cooling element isheated by energy emitted from microwave elements 110. In someembodiments, cooling element 140 may be fixedly coupled to substrate120. Cooling element may be configured to circulate a cooling medium,such as water, or may house, or be formed from a cooling medium, such asa cooling gel.

In one embodiment, a heat sink and heat pipe structure (collectively143) is embedded in a flexible and disposable fixture. The heat sinkcollects heat from the body surface and/or the microwave antennaelements. The heat pipe then wicks away the heat from the heat sink. Theheat sink and/or heat pipe may have internal temperature sensors toreport the current temperature of the system. If used in conjunctionwith temperature sensors on the skin, the system may be able todetermine the effectiveness of the cooling system. Effectiveness of thecooling system may also be a lead indicator of blockages or stoppages ofactive or passive portions of the system. These problems may includeheat sink fin buildup, clogged heat pipes, or lack of sufficient coolingmedium (air or water).

Monitoring assembly 160 may include one or more focused antenna 162.Each of focused antennas 162 may have a corresponding signalconditioners including pre-amps 164 and filters and positioner 166.Monitoring assembly 160 may have shielding 167 to shield the focusedantennas 162 from the control assembly 150. The shielding may berequired to avoid interference and to allow proper calibration anddetection by each focused antenna 162. The shielding 167 may be afabric, mesh, or any other suitable material. Important shielding mayinclude conductive shielding from the active antennas and theindividual's skin, thus preventing potentially substantial causes ofambient noise. The shielding 167 may be constructed as part of adisposable fixture, through materials such as conductive foam.

Focused antenna 162 may be positioned to detect changes of temperaturesin the body, such as kidneys 60. In some embodiments, multiple antennas162 may be used to detect temperatures in various locations in eachkidney 60, or of each kidney 60, independent of each other. Monitoringassembly 160 may be connected to control assembly 150 by connector 168.Similarly, a focused antenna 162 may be used to monitor the temperatureof urine 30 in bladder 20, and may be positioned with, or may beincorporated into heating assembly 100. In some embodiments, the desireddepth of measurement within the tissue may be adjusted based onphysiological and biometric data, as well as frequency and intensityadjustments.

The frequency may be adjusted based on several different factors. Theadjustment may be normalized on typical anatomy measurements. In someembodiments, the adjustment is based on inferred or measured data fromother imaging data, such as an ultrasound, MRI, or from prior baselinemeasurements. In other embodiments, the entire area may be imaged byvarying the sensor's detected frequency range.

Radiometer 180 b may be provided in control assembly 150, or inmonitoring assembly 160, to receive input from focused antennas 162 andprovide coherent data to PC 152 corresponding to the input from focusedantennas 162. In some embodiments, radiometer may be located inmonitoring assembly 160, within the shielding of monitoring assembly160.

Positioner 166 may be configured to work in conjunction with a fixtureof focused antenna 162 to allow a practitioner to direct the focusedantenna 162 to detect temperature in a desired location within body 70.A practitioner may locate one or more anatomical features to facilitatedesired positioning of focused antenna 162 over tissue, internal bodyportions and/or fluids at a depth to be monitored, such as a bladderwith urine, or a kidney. In some embodiments, a focused antenna may beplaced to detect both the temperature of urine in a bladder, and asecond focused antenna may be placed to detect the temperature of fluidsin a kidney. In some embodiments, the anatomical feature may be detectedusing ultrasound to ensure proper placement of focused antenna 162.Positioner 166 may then be used to hold focused antenna in place, andmay be adjusted as desired. The described methods of positioning offocused antenna 162 may also be used to position heating assembly 100.

Steps to use the device may include: Locating an anatomical featureassociated with a first desired internal body portion; positioning afirst device based on the locating the anatomical feature, wherein thefirst device is configured to alter a condition of the first internalbody portion; positioning a second device on the individual, wherein thesecond device is configured to monitor the condition of a secondinternal body portion; and applying microwave energy from the firstdevice to the individual, the energy being configured to increase thetemperature of the first internal body portion without injuring theindividual. Optional steps may include: further comprising monitoringthe condition of the second internal body portion; further comprisinglocating a second anatomical feature associated with the second desiredinternal body portion, wherein the positioning the second device isbased on the locating an anatomical features associated with the seconddesired internal body portion; or using an ultrasound device to locatethe anatomical feature.

In some embodiments, positioner 166 may be coupled to a seat 200, suchas is shown in FIG. 4, in an area located proximate to the portion of aindividual 205 to be monitored. Positioners 166 may provide formulti-axis positioning of focused antenna 162, to allow a practitionermaximum allowance to properly position focused antenna 162 with respectto a targeted point or region, such as a desired portion of a kidney.For example, positioners 166 may be coupled to seat 200 such that theattachment allows for adjustment laterally, vertically, and axially offocused antenna 162.

In some embodiments, positioner 166 may be disposable. For example, adisposable contact member with positioners 166 may be provided todirectly contact body 70, allowing monitoring assembly 160 to beattached in the appropriate location relative to body 70, while allowingfor the disposable contact member to be thrown away after each use, orwhen soiled by a individual being treated with system 10. For example,positioner 166 may include an adhesive portion for temporarily affixingpositioner 166 to an individual being treated.

In some embodiments, positioner 166 may include an impedance matchingelement 169 placed between focused antenna 162 and the individual beingtreated. The impedance matching element 169 may be selected based onmeasured biological data from the individual to allow focused antenna tobe tuned for each individual being treated. The impedance matchingelement may be formed from plastic, or other suitable material, and maybe physically designed to provide a desired impedance matching effect,such as thickness, density, etc. In some embodiments, the impedancematching element may be formed such that it may be affixed to theindividual being treated or diagnosed and may be used as a positioningaid to help place focused antenna 162 in correct position relative tothe physiology of the individual being treated.

In another embodiment, a fixture 121 may be adhesively applied to thebody 70. With reasonable placement, normal contours of the body maydirect the focused antenna 162 to the correct anatomic regions.Conductive foam 169 (i.e. an impedance matching element) may be usedaround the focused antenna 162 to shield the focused antenna 162 fromnoise. A dielectric foam may be applied between the antenna and the bodyto aid in a predictable electrical pathway to the desired target area.

The fixture 121 (FIG. 3) may be configured with a receptacle 171 toaccept and release the focused antenna 162 or an assembly containing thefocused antenna, such as a combination of antenna and radiometerLikewise the fixture 121 may have receptacle 171 for the passive antenna112 (which can function as a focused antenna). As the antenna and/orassembly may be expensive, reuse of the assembly may be cost effective.Thus, the disposable portion of the fixture 121 may include thereceptacle that directs the focused antenna 162 or passive antenna 112to the proper target area, while providing shielding.

The rate and magnitude of thermal change may be compared to expecteddata. The differences may indicate a disease and/or diagnosis as well asa measurement of severity. Further, the data may indicate or provide afactor of indication in the amount and duration of fluid migrationbetween bladder and kidney. Thus with normalized data, the system mayinclude a temperature trigger that may automate a portion of thediagnosis and/or determination of severity.

Measurements by the system of thermal changes may be converted to graphsor other visualizations of the measured data set, including colorreal-time manipulable 3 dimensional images. The visualizations may grantan operator a quicker understanding of the data. As discussed above, theimage data may be based in the integral of the temperature in thedirection of the temperature sensor (such as a radiometer). Moreresolution may be obtained by overlapping sensor detection areas,especially with a different direction. In fact, the image may aid theoperator's use and diagnosis in real-time. In some embodiments, theimage may be displayed on I/O device 154, as I/O device 154 may be oneor more of a monitor, touch screen monitor, or other data entry devicekeyboard, mouse, or any other I/O device desirable for use with system10.

In some embodiments, heating controller 156 may be used to control asafety turn-off based on temperatures monitored in or on body 70.Algorithms may be used to limit energy output based on the size and ageof the individual, inflated size of the bladder, thickness of muscle andintervening tissue, temperature sensors in the cooling apparatus, anytemperature sensors in the bladder and temperature sensors on the skin.For example, if input from temperature sensors 132, passive microwaveelement 112, focused antennas 162, or other input indicates thepossibility or likelihood of injury to body 70 or an anomalous reading,heating controller 156 may shut down the procedure to avoid injury tobody 70. Similarly, temperature inputs may be constantly monitored andthe output at microwave elements 110 adjusted accordingly to optimizethe heating rate and avoid injury or unwanted tissue damage according toanatomy. Such adjustment, safety shut-down and monitoring, may be doneautomatically by control assembly 150. Adjustments may include:selectively cycling which portion of the focused array emits energy;altering the duration of time the focused array emits energy; alteringthe period at which at least a portion of the focused array emits energytuning off the focused array, etc., such that an optimum energy may beemitted without damaging tissue.

In one embodiment, the heating assembly 100 and the monitoring assembly160 may be wirelessly coupled to the control assembly 150. The wirelesscoupling may allow the individual more comfort and/or freedom ofmovement. In some procedures, the individual may be required to urinatethe heated liquid. With wireless coupling, the individual may be able touse a normal restroom while being diagnosed.

With remote monitoring, the system may require more hardware that isrespectful of the equipment. For instance, the wireless communicationmay need to cease during the detection phase of a radiometer to reduceinterference. Thus, the system may need local storage to store andforward the results after the measurements. Procedures may also havedifferent power requirements. Thus a lower power procedure may use asmall portable power supply, such as a battery or fuel cell, that maystrap on the individual. Higher power procedures may require a powersupply that is separately wheeled by the individual or an attendant.

Turning now to FIG. 2, a schematic view of an emitted energy heating andmonitoring device is shown. The array may have two or more of microwaveelements 110. FIG. 2 illustrates four microwave elements 110. It will beappreciated that as many microwave elements 110 as desired may be usedin the array on heating assembly 100. In some embodiments, microwaveelements 110 may be lobes of a single microwave antenna, generatingseparate energy emissions from each lobe such that the lobes work in amanner similar to distinct microwave elements 110 as described below.

The heating assembly may include rigid microwave elements 110 on aflexible, disposable fixture 121 such as a band, strap or otherretention mechanism. The fixture 121 may contain or use a layer, such asa dielectric foam, allowing the microwave antenna a more predictableelectrical pathway to the focal area. The system may also be shielded toprevent the scattering of microwaves to the back or side of theassembly. This shielding may be accomplished through a backplane, moreconductive foam or other shielding methods.

Turning now to FIG. 3, a cross sectional view of an emitted energyheating and monitoring device 100 a in use on a individual is shown.Individual microwave antennas 110 may be directed to a focal area 116,such as urine in a individual's bladder. A cooling element 140 may beused to reduce the temperature of the skin as raised by the microwaveantennas. A passive antenna 112 (or focused antenna) may be used tomonitor the temperature at the focal area 116 and/or a target area fordiagnosis.

Thus, the heating and monitoring device 100 a, may form the heatingassembly 100 and be used in conjunction with the monitoring assembly160, or may be used for both functions in appropriate circumstances,i.e. determining temperature change in a relatively small area.

Turning now to FIG. 4, a seat 200 may be provided on a cabinet or base151 housing a control system 150. Similarly, monitoring system 160 maybe directly coupled to seat 200. Heating assembly 100 may be provided asa portion of seat 200, or as a device configured to be coupled to seat200. For example, seat 200 may be similar to a car seat familiar to achild, or may be a full-sized seat configured for receiving an adult. Insome embodiments, chair or seat 200 may include a formed portion and asoft portion covering part of the formed portion to provide acomfortable seating surface for individual 205. In some embodiments,seat 200 or portion thereof, may be formed or molded from a microwaveresistant plastic.

Heating assembly 100 may be coupled to a restraint portion 210, such asa lap belt, chest belt, restraint arm or other structure configured tobe positioned across a portion of the individual 205. The heatingassembly 100 and the monitoring system 160 may be fixedly attached tothe seat, or may be removable, to allow for different configurationsdepending on the particular anatomy of the individual which is the focusof testing. For example, the monitoring assembly may be slidable alongthe seat due to a plurality of slots, etc. so as to accommodatedifferent sized individuals.

In another embodiment, all or part of the heating assembly 100 isseparate from the seat 200 and restraint portion or lap band 210 and mayeven be disposable. Restraint portion 210 may include fasteners 212 and214, including a latch and latch receiver, for releasably securingrestraint portion 210 to seat 200. In some embodiments, positioners 166may be positioned to provide contact between focused antennas 162 andindividual 205.

Monitoring assembly 160 may be removably, or permanently coupled to seat200. Shielding of monitoring assembly 160 may be incorporated into seat200 and into restraint portion 210, where a shielded focused antennasimilar to those in monitoring assembly 160 may be used. An impedancematching foam may be attached to the seat such that it forms animpedance matching layer between the monitoring assembly and theindividual. The foam may also be made disposable, such that the foam maybe thrown away, resulting in a reduced cost of sanitizing the seat andsensors.

It will be appreciated that the relative position of the heating andmonitoring assemblies 100 and 160 will depend on the structures to beheated and monitored. Thus, it is conceivable that for certaindiagnostic procedures, the heating assembly may be attached to the seator seat 200 and the monitoring assembly may be held to the individual bya lap band, shoulder band, etc. Thus, the shielding and movability ofthe heating assembly 100 and monitoring assembly 160 may be reversed.

In one embodiment, the seat may be coupled with an entertainment system.Thus the individual may be entertained and relax while a procedure asdescribed in this disclosure is performed. The entertainment system mayinclude sound and/or video equipment. In one situation, the equipmentmay also contain a two-way communications system, such that theindividual may page or otherwise get the attention of health care staffor the staff may converse with the individual from a distance.

FIGS. 5A and 5B show an alternate configuration of the present inventionin which heating assembly 100 may be provided in holder such as agarment 300, which may be a disposable diaper for an infant or anundergarment for wearing by an adult. In other embodiments, heatingassembly 100 may be readily attachable to a disposable diaper, or may beotherwise provided in a package comfortable for an individual.

In some embodiments, portions of heating assembly 100 may be included ina disposable diaper, with others may be included in a restraint portionof seat 200 similar to that shown in FIG. 4. In some embodiments, seat200 and other accompanying elements may be constructed to resist themicrowave energy and to limit or eliminate unwanted microwave energyfrom being transmitted to the area around seat 200 or system 10.

Garment 300 may include coupling portion 310 with an interface, such asa pocket, which may allow for attaching at least a portion of heatingassembly 100 to garment 300. In some embodiments, garment 300 mayinclude open area 312 to allow heating assembly 100 to contact theindividual directly. Garment 300 may also include securement portion 330for attaching garment 300 to the individual. For example, securementportion 330 may be tabs that secure portions of garment 300 to itself.Securement portion 330 may be adjustable to allow garment 300 to beadjusted to allow heating assembly 100 to be located properly on theindividual depending on the individual's size. Garment 300 may includeabsorbent material 320, similar to a standard diaper or incontinenceundergarment. Since reflux generally occurs when a individual attemptsto urinate, having a disposable absorbent material 320 like in a diaperhelps to facilitate comfort during procedures. In some embodiments,garment 300 may also include cooling element 140, either integrallyformed in garment 300, or attached or otherwise inserted into garment300. In some embodiments, garment 300 may be disposable, with portionsof heating assembly 100 manufactured into garments 300, and disposableafter each use. In some embodiments, garments 300 may include access 314for a focused antenna 112, as discussed above, for separateinstallation. Similarly, in some embodiments, portions of garment 300,such as absorbent material 320 may include shielding materials to helpimprove the sensitivity of the various monitoring devices in system 10.

Turning now to FIG. 6, there is shown an alternate embodiment of aholder or garment 350 in accordance with the principles of the presentinvention. The garment 350 may be worn by a individual. The garment 350has the heating assembly 100 and the monitoring assembly 160 attachedthereto. All or part of the heating assembly 100 and/or the monitoringassembly 160 may be discarded with the garment 350. However, due to thecost of the focused antennas and radiometer assemblies, it is presentlypreferred to have at least those structures be removeably attached tothe garment 350 for reuse with further procedures.

Although system 10 has been described with microwave elements 110, otherheating methods may be provided and used with other portions of system10. Similarly, the components of system 10 may be provided in any numberof configurations, and not necessarily in the particular configurationsand locations illustrated in the Figures. For example, multiplexor 114may be located on substrate 120 of heating assembly 100, or PC 152 maybe remote from the rest of system 10, being connected wirelessly toother components of system 10. Other configurations and uses, eitherindividually or with one or more other components taught in the Figures,are contemplated by this application.

While the present invention has been discussed primarily with respect tovesicoureteral reflux, there are numerous other scenarios in which theprinciples of the present invention could be used. For example, systemsand methods in accordance with the present invention can be usedregarding the nervous system.

There is not a current imaging method that adequately shows flow of thecerebral spinal fluid through the aqueducts to and from the spinalcolumn. Current studies simply show dilatation of obstructed chambers.Warming either the spine or the head and measuring the temperature inthe opposite end (or some other location) of the nervous system wouldeasily show the migration of the warm cerebral spinal fluid through itsproper ductal network. This flow could be timed to know how rapid thisoccurs and whether any abnormalities exist.

Likewise, the present invention could be used in the dental field.Applications for the system and methods of the present invention may beas simple as having the patient drink a warm drink or a cold drink andmeasuring how rapidly the teeth returns a normal temperature, indicatinggood blood flow and viability of the teeth. Sensitivity to hot or coldis a common problem and difficult to determine exactly which tooth iscausing the problem. The systems and methods of the present invention,with their ability to determine actual temperatures may be very helpfulin determining the underlying condition.

Likewise, the present invention could be used in the pulmonary field.Anticipated benefits for imaging the pulmonary tree may be significant.Currently there are few diagnostic studies to determine ventilatorypatterns deep within the bronchial tree and the alveoli. The patientcould be asked to breathe warm or cold air and the systems and methodsof the present invention could measure temperature changes throughoutthe lung fields, determining which areas were easily ventilated andwatching their return to normal.

The systems and methods of the present invention could be used as a wayto watch the lung disease processes resolve. Once a patient has breathedwarm or cold air, the systems and methods of the present inventionshould be able to observe the normal blood vessels that don't changewith the ventilation temperature to determine perfusion in the lungs andought to be an alternative method to evaluate ventilation and perfusiondefects.

The systems and methods of the present invention could also be used inthe cardiovascular context. For example, an individual could have theheart warmed and then measurements of peripheral blood flow to any ofthe following arteries: carotid artery, femoral artery, brachial arterydescending aorta, etc. The systems and methods of the present inventioncould be used to measure peripheral vascular blood flow. Knowing howrapidly the heart was warmed a mathematical calculation of cardiacoutput could be performed.

As the resolution of the systems and methods of the present inventionimproves, it may be possible that the coronary vessels could be seendistinctly from the heart chambers themselves, allowing imaging that iscurrently only available by intravascular catheterizations. Conversely,if a peripheral area, such as a femoral area was warm, we could watchand calculate venous return to the heart, including cardiac output.

The systems and methods of the present invention could be used if thelung fields were warmed, either the right side or the left side, or bothsides at once, to observe the vascular tree of the lungs, both pulmonaryartery and pulmonary venous systems could be well-delineated.

If an IV was in place an injection of cold bolus of fluid of knownamount could be injected and the systems and methods of the presentinvention could be used to measure the temperature and withthermodilution calculations the cardiac output could be determinedaccurately.

The systems and methods of the present invention could be used in thegenitourinary system (besides vesicoureteral reflux). For example, ifthe kidney were warm, the urine flowing to the bladder could be seen andmeasured alleviating the need for an intravenous pyelogram (WP) and atmuch diminished expense from a CT scan. Warmed bladder urine could beobserved during the voiding process and perhaps eliminate the need forvoiding cystoureterograms in non-refluxing patients.

On occasions renal cysts are difficult to delineate from a diverticulaof the collecting system, which does have a communication with thecollecting system. If the fluid pocket was warm and the temperaturechanges, one could tell it was a diverticulum with the communication tothe kidney and if the temperature simply diffused through the kidney,one would know this is a cyst without fluid communication.

Regarding, GI imaging, swallowing warm or cold fluid could be used inconjunction with the systems and methods of the present invention, asthe temperature monitoring devices may be used to evaluate esophagustransit and stomach transit times. If the stomach were warm, observationof the esophagus would determine whether there was gastroesophagealreflux. If the stomach were warmed or if warm or cold fluids wereswallowed, the intestinal transit time may be calculateable with thesystems and methods of the present invention

Likewise, the traditional barium enema to study the large intestine maystill require and catheter and fluid to be placed, but the temperatureof the fluid could be adjusted so that the systems and methods of thepresent invention could be the imaging modality of choice so that noionizing radiation is required.

Similarly, the flow of bile from the gallbladder, through the bile ductcould be imaged by warming the gallbladder and watching the warm bile godown the duct into the duodenum. The systems and methods of the presentinvention could render such monitoring relatively easy and noninvasive.

In obstetrics and gynecology, the hysterosalpingogram study to determinepatency of the fallopian tubes could be done with a cold solution andimaged with the systems and methods of the present invention so that noionizing radiation would be necessary, especially in the area of thegonads, which can be damaging.

Likewise, during pregnancy, the amniotic fluid could be warmed and theturn over time of the amniotic fluid could be measured, fetal swallowingcould be observed and fetal urination would be visible.

In orthopedics, joint spaces have fluid and the fluid could be warmedand observed for even distribution throughout the joint space. This maybe a desirable tool for physical therapy for measuring how deep thetissues are being heated and how rapidly the damaged tissue isresponding and returning to normal blood flow.

Regarding solid organs, or tissues, scar tissues should warm muchdifferently than normal surrounding tissue because of missed blood flowand over time it would be anticipated that the scar tissue would coolmore slowly since there is less blood flow to take the warmth away fromthe scar. This would help physicians determine whether there was scartissue or inflammation.

Within inflamed tissue there should be increased blood flow, whichshould have a different warming characteristic of scar tissue and withthe increased blood flow it would be expected that they inflamed tissuewould cool faster as the increased blood flow would take the temperatureaway.

As will be apparent to those skilled in the art in which the inventionis addressed, the present invention may be embodied in forms other thanthose specifically disclosed above without departing from the spirit orpotential characteristics of the invention. Particular embodiments ofthe present invention described above are therefore to be considered inall respects as illustrative and not restrictive. The scope of thepresent invention is as set forth in the appended claims and equivalentsthereof rather than being limited to the example contained in theforegoing description.

1. A tissue heating and monitoring system, comprising: a heatingassembly comprising: an array of microwave antennas, configured to pointat a focal area, and a first temperature monitoring device; a chairconfigured to accommodate an individual; a controller operativelycoupled to the chair and the heating assembly; and a second temperaturemonitoring device disposed in communication with the controller, whereinthe second temperature monitoring device is attached to the chair suchthat internal tissue of an individual sitting in the chair may bemonitored by the second temperature monitoring device.
 2. The system ofclaim 1, wherein the heating assembly is configured to be placed on skinof the individual over the bladder.
 3. The system of claim 1, whereinthe second temperature monitoring device is configured to be placed overthe kidney of an individual.
 4. The system of claim 1, wherein thesecond temperature monitoring device forms a monitoring assemblycomprising at least one focused antenna.
 5. The system of claim 4,wherein the at least one focused antenna further comprises shieldingconfigured to reduce ambient energy to the focused antenna.
 6. Thesystem of claim 1, wherein at least a portion of the heating assembly iscoupled to the chair.
 7. The system of claim 1, wherein at least aportion of the heating assembly is attached to a structure configured tobe worn by the individual.
 8. The system of claim 1, further comprisinga cooling system configured to remove heat from the individual.
 9. Thesystem of claim 8, wherein at least a portion of the cooling system isformed with the heating assembly.
 10. The system of claim 8, wherein thecontroller is functionally coupled to the heating assembly, the secondtemperature monitoring device, and the cooling system.
 11. The system ofclaim 10, wherein the controller forms a control assembly configured tocontrol the heating assembly, the second temperature monitoring device,and the cooling system.
 12. The system of claim 1, wherein the controlassembly further comprises an I/O interface.
 13. The system of claim 12,wherein the I/O interface includes a data entry device and a monitor.14. The system of claim 1, further comprising a cabinet coupled to thechair, wherein the controller forms a portion of a control assemblywhich is substantially located within the cabinet.
 15. The system ofclaim 14, wherein the cabinet includes a portion configured toaccommodate an I/O interface.
 16. The system of claim 1, wherein thechair further comprises an entertainment device configured to deliverentertainment to the individual.
 17. The system of claim 1, wherein thesecond temperature monitoring device forms a part of a monitoringassembly and wherein the monitoring assembly is attached to the chair18. The system of claim 17, further comprising an impedance matchinglayer disposed adjacent the monitoring assembly.
 19. The system of claim17, wherein the impedance matching layer comprises a material removablydisposed on the chair so as to isolate the individual from themonitoring assembly.
 20. A diagnostic system comprising: a chairconfigured for sitting in by a individual; a heating assemblycomprising: an array of spaced apart microwave antennas, configured topoint at a focal area; a monitoring assembly comprising at least onetemperature monitoring device, the monitoring assembly being remote fromthe heating assembly; and a control assembly disposed in communicationwith the heating assembly and the monitoring assembly, wherein at leastone of the heating assembly and the monitoring assembly is attached tothe chair.
 21. The diagnostic system of claim 20, wherein the heatingassembly comprises a temperature monitoring device and wherein thecontroller is configured to adjust the heating assembly responsive tosignals generated by the temperature monitoring device.
 22. Thediagnostic system of claim 20, wherein monitoring device comprises aplurality of temperature monitoring devices configured for detectingtemperature inside of a individual at a desired location.
 23. A chairfor use with a tissue heating and monitoring system, comprising: a seatconfigured for receiving an individual; at least one focused antennadisposed adjacent the seat and configured to monitor the individual inthe seat; shielding, wherein the shielding is configured to isolate thefocused antenna from ambient energy; and a restraint portion configuredto secure the individual in the seat.
 24. The chair of claim 23, whereinthe shielding is a fabric.
 25. The chair of claim 23, wherein therestraint portion further comprises a housing configured to hold afocused array configured to supply energy to the individual.
 26. Thechair of claim 25, wherein the focused array is configured to supplyenergy to urine in the bladder of the individual.
 27. The chair of claim23, wherein the focused antenna is configured to monitor an internalcondition of the individual.
 28. The chair of claim 27, wherein theinternal condition is the temperature of at least a portion of a kidney.29. The chair of claim 23, wherein the restraint portion is a molded armhingedly coupled to the seat, and wherein a heating assembly is disposedin the arm.
 30. The chair of claim 23, wherein the formed portionincludes microwave shielding portions.